164 F.3d 650 (D.C. Cir. 1999), 98-5043, Pearson v. Shalala

Docket Nº:98-5043, 98-5084.
Citation:164 F.3d 650
Party Name:Durk PEARSON and Sandy Shaw, American Preventive Medical Association and Citizens for Health, Appellants, v. Donna E. SHALALA, Secretary, United States Department of Health and Human Services, et al., Appellees.
Case Date:January 15, 1999
Court:United States Courts of Appeals, Court of Appeals for the District of Columbia Circuit

Page 650

164 F.3d 650 (D.C. Cir. 1999)

Durk PEARSON and Sandy Shaw, American Preventive Medical

Association and Citizens for Health, Appellants,


Donna E. SHALALA, Secretary, United States Department of

Health and Human Services, et al., Appellees.

No. 98-5043, 98-5084.

United States Court of Appeals, District of Columbia Circuit

January 15, 1999

Argued Dec. 1, 1998.

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Appeals from the United States District Court for the District of Columbia (95cv01865).

Jonathan W. Emord, Burke, VA, argued the cause for appellants. With him on the briefs were James S. Turner, Bellevue, WA, and Betsy E. Lehrfeld.

Christine N. Kohl, Attorney, United States Department of Justice, argued the cause for appellees. With her on the brief were Frank W. Hunger, Assistant Attorney General, Wilma A. Lewis, United States Attorney, and Douglas N. Letter, Attorney, United States Department of Justice.

Nancy T. Lord-Johnson was on the brief for amici curiae Direct Aids Alternative Information Resources, et al.

David C. Vladeck, Allison M. Zieve, and Bruce Silverglade were on the brief for amici curiae American Cancer Society, et al.

Before: WALD, SILBERMAN, and GARLAND, Circuit Judges.

SILBERMAN, Circuit Judge:

Marketers of dietary supplements must, before including on their labels a claim characterizing the relationship of the supplement to a disease or health-related condition, submit the claim to the Food and Drug Administration for preapproval. The FDA authorizes a claim only if it finds "significant scientific agreement" among experts that the claim is supported by the available evidence. Appellants failed to persuade the FDA to authorize four such claims and sought relief in the district court, where their various constitutional and statutory challenges were rejected. We reverse.


Dietary supplement marketers Durk Pearson and Sandy Shaw, presumably hoping to bolster sales by increasing the allure of their supplements' labels, asked the FDA to authorize four separate health claims. (Pearson and Shaw are supported by two other appellants, the American Preventive Medical Association, a health care advocacy organization whose members are health care practitioners, and Citizens for Health, a health care advocacy organization whose members are consumers of dietary supplements.) A "health claim" is a "claim made on the label or in labeling of ... a dietary supplement that expressly or by implication ... characterizes the relationship of any substance to a disease or health-related condition." 21 C.F.R. § 101.14(a)(1) (1998). Each of appellants'

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four claims links the consumption of a particular supplement to the reduction in risk of a particular disease:

(1) "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers."

(2) "Consumption of fiber may reduce the risk of colorectal cancer."

(3) "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."

(4) ".8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form."

Understanding the preapproval requirement for health claims on dietary supplements requires a brief excursus on the broader regulatory framework applicable to dietary supplements, foods, and drugs. A "dietary supplement" is a "product (other than tobacco) intended to supplement the diet" that contains one or more of certain dietary ingredients, including a vitamin, a mineral, an herb or other botanical, or an amino acid, 21 U.S.C.A. § 321(ff)(1)(A)-(D) (Supp.1998) (emphasis added), "is not represented for use as a conventional food or as a sole item of a meal or the diet," id. § 321(ff)(2)(B), and "is labeled as a dietary supplement," id. § 321(ff)(2)(C). A "drug" includes, inter alia, "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." 21 U.S.C.A. § 321(g)(1)(B) (Supp.1998). If the product is a "new drug," the product must survive the arduous drug approval process, see 21 U.S.C.A. § 355 (Supp.1998), before the manufacturer may introduce it into interstate commerce, id. § 355(a); see also 21 U.S.C.A. § 343(r)(1)(B) (Supp.1998) (deeming "misbranded" a dietary supplement whose label includes a health claim); 21 U.S.C. § 331 (1994) (prohibiting the introduction of a misbranded product into interstate commerce); 21 U.S.C.A. § 333 (Supp.1998) (prescribing penalties for violations of § 331).

Although there is apparently some definitional overlap between drugs and dietary supplements under the statute, it creates a safe harbor from designation as a "drug" for certain dietary supplements whose labels or labeling 1 advertise a beneficial relationship to a disease or health-related condition: If the FDA authorizes a label claim under 21 U.S.C.A. § 343(r), the product is not considered a drug under 21 U.S.C.A. § 321(g)(1). The FDA authorizes a claim only

when it determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.

21 C.F.R. § 101.14(c) (1998). The FDA's authorization comes by an informal rulemaking under the Administrative Procedure Act. See 21 C.F.R. § 101.70 (1998); 5 U.S.C. § 553 (1994). This choice of a rulemaking rather than an adjudication--which would seem a more natural fit for this individualized determination--was mandated by Congress for the regulation of health claims on food labels, see 21 U.S.C.A. § 343(r)(3)(B)(i), and then adopted by the FDA as well for the regulation of health claims on dietary supplement labels, see id. § 343(5)(D) (authorizing but not specifying regulatory procedure); 21 C.F.R. § 101.70.

The requirement that health claims be approved before being added to the label of a dietary supplement constitutes the primary regulatory hurdle faced by marketers of dietary supplements. The actual sale of dietary supplements is regulated only when the supplement contains a "new dietary ingredient," 21 U.S.C.A. § 350b (Supp.1998), or poses a safety risk, id. § 342(f). See also Food Labeling; General Requirements for Health Claims for Dietary Supplements, 59 Fed.Reg. 395, 396 (1994) (explaining that "the availability

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of dietary supplements will not be affected by these regulations [of health claims]").

The safe harbor from "drug" status for dietary supplements bearing FDA-approved health claims did not always exist. Prior to 1984, the FDA took the position that a statement that consumption of a food could prevent a particular disease was "tantamount to a claim that the food was a drug ... and therefore that its sale was prohibited until a new drug application had been approved." H.R.REP. NO. 538, 101st Cong., 2d Sess. 9 (1990), reprinted in 1990 U.S.CODE CONG. & ADMIN.NEWS 3336, 3338. But during the mid-1980s, companies began making health claims on foods without seeking new drug approval, a practice that the FDA supported in regulations proposed in 1987. Id. at 3338-39. Congress became concerned that health claims were increasingly common in the marketplace, and that the FDA had not issued clear, enforceable rules to regulate such claims. Id.

Against this background, and in light of the further concern that the FDA might lack statutory authority to permit health claims on foods without also requiring that the claim meet the premarket approval requirements applicable to drugs, see id., Congress enacted the Nutrition Labeling and Education Act of 1990 (NLEA), Pub.L. No. 101-535, 104 Stat 2353 (codified as amended at 21 U.S.C.A. §§ 301, 321, 337, 343, 371 (1972 & Supp.1998)). The NLEA addressed foods and dietary supplements separately. A health claim on a food may be made without FDA approval as a new drug, or the risk of sanctions for issuing a "misbranded" product, if it has been certified by the FDA as supported by "significant scientific agreement." Id. § 343(r)(3)(B)(i). Congress created a similar safe harbor for health claims on dietary supplements, but delegated to the FDA the task of establishing a "procedure and standard respecting the validity of [the health] claim." Id. § 343(r)(5)(D).

The FDA has since promulgated 21 C.F.R. § 101.14--the "significant scientific agreement" "standard" (quoted above)--and 21 C.F.R. § 101.70--a "procedure" (not particularly relevant to this case)--for evaluating the validity of health claims on dietary supplements. 2 In doing so, the agency rejected arguments asserted by commenters--including appellants--that the "significant scientific agreement" standard violates the First Amendment because it precludes the approval of less-well supported claims accompanied by a disclaimer and because it is impermissibly vague. See 59 Fed.Reg. 395, 405, 422-23 (1994). The FDA explained that, in its view, the disclaimer approach would be ineffective because "there would be a question as to whether consumers would be able to ascertain which claims were preliminary [and accompanied by a disclaimer] and which were not," id. at 405, and concluded that its prophylactic approach is consistent with applicable commercial speech doctrine, see id. at 423 (discussing Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n, 447 U.S. 557, 563-64, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980)). The agency, responding to the comment that "significant scientific agreement" is impermissibly vague, asserted that the standard is "based on objective factors" and that its procedures for approving health claims, including the notice and comment procedure...

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